Business Wire

Oxford BioMedica Notes the Longer-Term Analyses from Pivotal Kymriah® Trials, Which Showed Durable Responses Are Maintained in Patients with Advanced Blood Cancers

Del

Oxford BioMedica plc (“Oxford BioMedica” or “the Group”) (LSE:OXB), a leading gene and cell therapy group, today notes an announcement by Novartis on the longer-term analyses of both the ELIANA and JULIET pivotal trials in children and young adult patients with relapsed or refractory (r/r) acute lymphoblastic leukaemia (ALL) and adult patients with r/r diffuse large B-cell lymphoma (DLBCL), respectively. Kymriah® (tisagenlecleucel) continued to demonstrate strong efficacy with durable responses and maintained a consistent and well-characterised safety profile. These data are being presented at the 60th American Society of Hematology (ASH) annual meeting. Additionally, today, the New England Journal of Medicine published online the 14-month results from JULIET, the study led by the Abramson Cancer Center at the University of Pennsylvania 1.

In the 24-month follow-up analysis of the ELIANA study in children and young adults with r/r B-cell ALL, Kymriah demonstrated deep and durable responses without subsequent therapy in a significant portion of patients in this population. Among 79 evaluable patients, who were followed for at least three months or discontinued earlier, 82% (95% confidence interval [CI], 72% - 90%) achieved complete response (CR) or CR with incomplete blood count recovery (CRi) within three months of infusion; and among these responding patients, 98% had negative minimal residual disease (MRD). The relapse-free survival rate was 62% at 24 months; and the median duration of remission (mDOR) and median overall survival (mOS) remained unreached, signifying responses are deep and sustained, and further reinforcing the potential for Kymriah to be a definitive therapy for many patients. The probability of OS was 76% (95% CI, 65% - 85%) at 12 months and 66% (95% CI, 58% - 79%) at 24 months. The safety profile observed in this updated analysis was consistent with previously reported results, with no emergence of new safety signals. Grade 3/4 cytokine release syndrome (CRS) – as defined by the rigorous Penn Grading Scale – occurred in 49% of patients. Within eight weeks of infusion, 13% of patients experienced grade 3 neurological events, with no grade 4 events or cerebral oedema2. These updated data will be presented in an oral session at the ASH annual meeting (Abstract # 895; Monday, December 3, 4:30PM PST).

Results from the 19-month analysis from the JULIET study of Kymriah in adult patients with r/r DLBCL (n=99) indicated prolonged durability of response in patients who had previously been through multiple rounds of chemotherapy and unsuccessful stem cell transplants (Abstract # 1684). The overall response rate (ORR) after a median of 19 months of follow-up was 54% (95% CI, 43% - 64%; CR, 40%; partial response [PR], 13%) among patients who were followed for at least 3 months or discontinued earlier. The mDOR was not reached at the time of analysis indicating most responders were still experiencing a response at the time of analysis; and the relapse-free probability, which was 66% (95% CI, 51%-78%) at 6 months, remained consistent at 64% (95% CI, 48%-76%) between 12-month and 18-month analyses. Further, 54% (15/28) of patients who had achieved a PR converted to CR. Median OS for all infused patients was 11.1 months (95% CI, 6.6 months-NE) and not reached (95% CI, 21 months-NE) for patients in CR. The OS probability was 48% (95% CI, 38%-57%) at 12 months and 43% (95%CI, 33%-53%) at 18 months (max follow-up, 29 months). Analyses of ORR, DOR and OS data showed consistent results across all patient subgroups, regardless of relapsed/refractory status, age and high-risk cytogenetics.

The safety profile observed in the 19-month follow-up from JULIET continued to be consistent with previous reports and no deaths occurred due to causes other than disease progression in this longer-term follow up analysis. Within eight weeks of infusion with Kymriah, Grade 3/4 CRS, as defined by the Penn Grading Scale, was reported in 23% of patients. CRS management was conducted per the Penn CRS management algorithm, which is specific to Kymriah. Tocilizumab and steroids were used in 16% and 11% of patients, respectively, to treat CRS. Eleven percent of patients had Grade 3/4 neurologic adverse events, which were managed with supportive care3.

Oxford BioMedica is the sole manufacturer of the lentiviral vector used in Kymriah. The Group signed an agreement with Novartis in July 2017 for the commercial and clinical supply of lentiviral vectors used to generate Kymriah and other undisclosed CAR-T products. This collaboration has reached important milestones in 2018 with the US FDA approval of Kymriah to treat adult patients with r/r DLBCL, and the approval of Kymriah in these two distinct indications in the European Union, Canada and Switzerland. These important achievements follow the initial US launch of Kymriah in paediatric and young adult patients with r/r B-cell ALL in 2017. Oxford BioMedica signed an agreement with Novartis in July 2017 for the commercial and clinical supply of lentiviral vectors used to generate CTL019 and other undisclosed CAR-T products, for which Oxford BioMedica could potentially receive in excess of $100m from Novartis over the next three years.

Notes for editors

About the ELIANA Trial

ELIANA is the first paediatric global CAR-T cell therapy registration trial, examining patients in 25 centres in 11 countries across the US, Canada, Australia, Japan and the EU, including: Austria, Belgium, France, Germany, Italy, Norway and Spain, demonstrating effective distribution of Kymriah across four continents using a global supply chain. In 2012, Novartis and Penn entered into a global collaboration to further research, develop and commercialize CAR-T cell therapies, including Kymriah, for the investigational treatment of cancers.

About the JULIET Trial

JULIET is the first multi-centre global registration study for Kymriah in adult patients with r/r DLBCL. JULIET, led by researchers at the University of Pennsylvania, is the largest and only global registration study examining a CAR-T cell therapy in DLBCL, enrolling patients from 27 sites in 10 countries across the US, Canada, Australia, Japan and Europe, including Austria, France, Germany, Italy, Norway and the Netherlands.

About Kymriah

In August 2017, Kymriah became the first available chimeric antigen receptor T cell (CAR-T) therapy when it received FDA approval for children and young adults with B-cell acute lymphoblastic leukaemia (ALL) that is refractory or has relapsed at least twice. Kymriah is a novel immunocellular therapy and a one-time treatment that uses a patient’s own T cells to fight cancer. Kymriah uses the 4-1BB costimulatory domain in its chimeric antigen receptor to enhance cellular expansion and persistence.

About Oxford BioMedica

Oxford BioMedica (LSE:OXB) is a leading gene and cell therapy group focused on developing life changing treatments for serious diseases. Oxford BioMedica and its subsidiaries (the "Group") have built a sector leading lentiviral vector delivery platform (LentiVector®), which the Group leverages to develop in vivo and ex vivo products both in-house and with partners. The Group has created a valuable proprietary portfolio of gene and cell therapy product candidates in the areas of oncology, ophthalmology and CNS disorders. The Group has also entered into a number of partnerships, including with Novartis, Bioverativ, Sanofi, Axovant, Orchard Therapeutics, Boehringer Ingelheim/UK Cystic Fibrosis Gene Therapy Consortium/Imperial Innovations and GC LabCell, through which it has long-term economic interests in other potential gene and cell therapy products. Oxford BioMedica is based across several locations in Oxfordshire, UK and employs more than 360 people. Further information is available at www.oxb.com.

________________________
1 Schuster S., et. al. Tisagenlecleucel in Adult Relapsed/Refractory Diffuse Large B-Cell Lymphoma. New England Journal of Medicine. December 2018.
2 Grupp S., et al. Updated Analysis of the Efficacy and Safety of Tisagenlecleucel in Pediatric and Young Adult Patients with Relapsed/Refractory (r/r) Acute Lymphoblastic Leukemia. 60th American Society of Hematology Annual Meeting and Exposition. Abstract #112599.
3 Schuster S., et. al. Sustained Disease Control for Adult Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma: An Updated Analysis of Juliet, a Global Pivotal Phase 2 Trial of Tisagenlecleucel, Acute Lymphoblastic Leukemia. 60th American Society of Hematology Annual Meeting and Exposition. Abstract #: 11525.

Contact information

Oxford BioMedica plc:
John Dawson, Chief Executive Officer
Stuart Paynter, Chief Financial Officer
Sarah MacLeod, Head of Communications
Tel: +44 (0)1865 783 000
media@oxb.com

Consilium Strategic Communications
Mary-Jane Elliott/Matthew Neal/Laura Thornton
Tel: +44 (0)20 3709 5700

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

NIPPON Platform Has Established the Ninth Overseas Branch "NIPPON Platform OÜ" in Estonia22.5.2019 02:00:00 CESTPressemelding

NIPPON Platform Co., Ltd. (CEO: Jun Takagi, Tokyo, Japan) established the subsidiary "NIPPON Platform OÜ" in Estonia on 8 May 2019. This is the ninth overseas branch for NIPPON Platform. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190521006004/en/ Overseas Subsidiaries (Graphic: Business Wire) “Making Japan into a cashless society” and “Revitalizing local societies and rural development with small and medium-sized retailers” are the motto for NIPPON Platform, and we provide various cashless payment solutions. • As a deployment base for the EU market Estonia is the most northerly of the three Baltic states, and has a population of 1.3 million people. Estonia has experienced rapid growth. Key sectors include manufacturing and IT. The parking charge may be paid via the mobile phone. 95% of residents in Estonia use the system to submit their annual income tax returns, and it will be completed in 5 minutes. Estonia is one of t

Jefferies Establishes Global Microstrategy Research22.5.2019 00:00:00 CESTPressemelding

Jefferies announced today the appointment of Desh Peramunetilleke as Head of Global Microstrategy Product in Equity Research. He is based in the firm’s Hong Kong office. Desh heads up the newly-formed Microstrategy team, which includes Mahesh Kedia, Shrikant Kale, Barnis Yuen, Jeffrey Tong and Jenny Wu. Microstrategy is a bottom-up product that uses company fundamentals to create insights into markets and sectors, and combines it with top-down macro trends to develop systematic investment strategies, diagnostic screens and proprietary risk scores for clients all over the world and across investment styles. “We are very excited to have Desh join Jefferies’ leading equities platform,” commented Peter Forlenza, Jefferies’ Global Head of Equities. “We are substantially expanding our Asian equities platform given our outlook on the Asian regional markets and the opportunity. Jefferies is perhaps singular in the industry currently to have the intent and ability to enlist such impressive team

PVH Corp. Names Stefan Larsson to Newly Created Role of President21.5.2019 20:23:00 CESTPressemelding

PVH Corp. [NYSE:PVH], one of the world’s largest apparel companies and owner of iconic brands, including CALVIN KLEIN, TOMMY HILFIGER, Van Heusen, Speedo, and IZOD, announced today the appointment of Stefan Larsson to the newly created role of President, PVH Corp. effective June 3, 2019. Mr. Larsson will have the responsibility for managing PVH’s branded businesses and regions, with each of the three brand CEOs and the Regional Presidents reporting to him. He will report to Emanuel Chirico, PVH’s Chairman and Chief Executive Officer. In connection with this announcement, Mr. Chirico signed a new five-year employment agreement with the Company. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190521005894/en/ PVH Corp. announced leadership updates, including Chairman and CEO Manny Chirico signing a new five-year employment agreement and hiring Stefan Larsson as PVH President, a newly created role. (Photo: Business Wire) PVH Pre

Gilead Sciences to Present at the Jefferies 2019 Global Healthcare Conference on Wednesday, June 521.5.2019 20:01:00 CESTPressemelding

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that Daniel O’Day, Gilead’s Chairman and Chief Executive Officer, will participate in a fireside chat at the Jefferies 2019 Global Healthcare Conference in New York on Wednesday, June 5 at 11:30 a.m. Eastern Time. The audio portion of the fireside chat will be accessible live through the company’s Investors page at http://investors.gilead.com/. Please connect to the company’s website at least 15 minutes prior to the start of the presentation to ensure adequate time for any software download that may be required to listen to the webcast. The replay will be available for 14 days following the presentation. About Gilead Sciences Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 3

Philip Morris International Strengthens Organizational Capabilities to Realize Its Vision for a Smoke-Free Future21.5.2019 18:44:00 CESTPressemelding

Philip Morris International Inc. (PMI) (NYSE:PM) today announced leadership moves to accelerate the realization of its vision of a smoke-free future and further enhance business growth. The company has created the following new roles: Chief Consumer Officer (CCO), Chief Life Sciences Officer (CLSO), Chief Product Officer (CPO) and Chief New Ventures Officer (CNVO). “Since the launch of our smoke-free product, IQOS, in 2014, we have made enormous progress both in terms of organizational capabilities, know-how and in our business results. With IQOS commercialized in 47 markets today, we are extremely proud of what has been achieved to date, including two recent milestones: realizing 10 million users and the U.S. FDA authorization to commercialize this smoke-free alternative in the U.S.,” said André Calantzopoulos, PMI’s Chief Executive Officer. “To accelerate, we must further enhance our ability to stay at the forefront of technology, science and consumer centricity.” All four executive

Virgin Voyages Expands Epic Entertainment Lineup21.5.2019 16:59:00 CESTPressemelding

Today, Virgin Voyages announces a series of exciting updates for its irresistible 2020 sailings. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190521005809/en/ Virgin Voyages Expands Epic Entertainment Lineup. (Photo: Business Wire) Expanded Partnership with Mark Ronson With a heritage deeply rooted in music, Virgin Voyages announced an expanded partnership with Academy, Grammy and Golden Globe-winning artist and producer Mark Ronson. Ronson will join the company’s Creative Collective, a group of world-class tastemakers, artists and designers who are collaborating with Virgin Voyages to bring epic Sailor experiences to sea. In his role as the company’s “Minister of Music,” Ronson will be creating a series of pre-voyage and onboard playlists for Sailors, as well as curating the vinyl record selection in the RockStar Suites and the ship’s vinyl and music shop – Voyage Vinyl. What’s more, Ronson will be working with Virgin Voy